levofloxacin

lee-voe-FLOX-a-sin

Oral route(Tablet;Solution)

Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. Risk further increases with age over 60 years, concomitant steroid therapy, and kidney, heart, or lung transplants. Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis .

Commonly used brand name(s)

In the U.S.

• Levaquin

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For levofloxacin

Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to prevent an anthrax infection after a person has been exposed to anthrax.

Levofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing bacteria or preventing their growth. However, levofloxacin will not work for colds, flu, or other virus infections.

levofloxacin is available only with your doctor's prescription.

Before Using levofloxacin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For levofloxacin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to levofloxacin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use is not recommended for infants, children, or teenagers. However, levofloxacin may be used in children to prevent an anthrax infection after a possible exposure.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levofloxacin in the elderly. However, elderly patients are more likely to have age-related tendon disorders (including tendon rupture) and kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving levofloxacin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking levofloxacin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using levofloxacin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Dronedarone


• Mesoridazine


• Pimozide


• Sparfloxacin


• Thioridazine

Using levofloxacin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Acecainide


• Acetohexamide


• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Benfluorex


• Bretylium


• Chloroquine


• Chlorpromazine


• Chlorpropamide


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Granisetron


• Guar Gum


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Lapatinib


• Lopinavir


• Lumefantrine


• Mefloquine


• Metformin


• Methadone


• Miglitol


• Moricizine


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Perphenazine


• Posaconazole


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Sematilide


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Theophylline


• Tolazamide


• Tolbutamide


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Troglitazone


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Warfarin


• Ziprasidone

Using levofloxacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Betamethasone


• Calcium


• Corticotropin


• Cortisone


• Cosyntropin


• Deflazacort


• Dexamethasone


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Fludrocortisone


• Fluocortolone


• Hydrocortisone


• Iron


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Methylprednisolone


• Paramethasone


• Prednisolone


• Prednisone


• Triamcinolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of levofloxacin. Make sure you tell your doctor if you have any other medical problems, especially:

• Behavior or mood changes or


• Diabetes or


• Epilepsy or


• Heart rhythm problems (eg, prolonged QT interval) or


• Seizures (convulsions)—Use with caution. May make these conditions worse. .

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Myasthenia gravis (severe muscle weakness)—Should not be used in patients with this condition.

• Organ transplant (eg, kidney, heart, or lung) or


• Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May increase the risk for tendon problems.

Proper Use of levofloxacin

Take levofloxacin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

levofloxacin comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Levofloxacin oral liquid should be taken 1 hour before or 2 hours after eating. You may measure your dose with a marked measuring spoon, oral syringe, or medicine cup.

Levofloxacin tablets may be taken with meals or on an empty stomach.

levofloxacin is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of levofloxacin.

levofloxacin works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.

If you need to take levofloxacin for anthrax infection, your doctor will want you to begin taking it as soon as possible after you are exposed to anthrax.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take levofloxacin. It is best to take these medicines at least 2 hours before or 2 hours after taking levofloxacin. These medicines may keep levofloxacin from working properly.

Keep using levofloxacin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of levofloxacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of levofloxacin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral solution or tablets):
  
  • For treatment of an infection:
    
    • Adults—250 to 750 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For preventing anthrax infection:
    
    • Adults—500 milligrams (mg) once a day.
    
    
    • Children 6 months of age and older, weighing more than 50 kilograms (kg)—500 mg once a day.
    
    
    • Children 6 months of age and older, weighing less than 50 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 mg per kg of body weight per dose, given two times a day. However, the dose is usually not more than 250 mg.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of levofloxacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using levofloxacin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

levofloxacin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash; itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you take levofloxacin.

Serious skin reactions can occur with levofloxacin. Stop using levofloxacin and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using levofloxacin.

Levofloxacin may cause serious liver problems, including hepatitis. Stop taking levofloxacin and check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you are using levofloxacin.

Levofloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using levofloxacin. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Stop using levofloxacin and tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

For patients with low potassium levels or an abnormally slow heartbeat: Levofloxacin may increase your risk of having a fast, slow, or irregular heartbeat. Call your doctor right away if you feel that your heart is not beating normally.

Some people who take levofloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn or skin rash, redness, itching, or discoloration. When you begin taking levofloxacin:

• Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.


• Wear protective clothing, including a hat and sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.


• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Levofloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to levofloxacin before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Levofloxacin may rarely cause inflammation or even tearing of a tendon (the cord that attaches muscles to the bones). The risk of having tendon problems may be increased if you are over 60 years of age, using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or have received an organ (eg, heart, kidney, or lung) transplant. If you get sudden pain or swelling in a tendon after exercise (eg, in the ankle, back of the knee or leg, shoulder, elbow, or wrist), stop using levofloxacin and check with your doctor right away. Refrain from exercise until your doctor says otherwise.

For diabetic patients taking insulin or diabetes medicine by mouth: Levofloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, stop taking levofloxacin and check with your doctor right away:

• Symptoms of low blood sugar can include: Anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty with concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

Before you have any medical tests, tell the medical doctor in charge that you are using levofloxacin. The results of some tests may be affected by levofloxacin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

levofloxacin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Diarrhea

Rare

• Abdominal or stomach cramps or pain (severe)


• agitation


• blisters


• confusion


• diarrhea (watery and severe) which may also be bloody


• feeling that others can hear your thoughts or control your behavior


• fever


• pain, inflammation, or swelling in the calves of the legs, shoulders, or hands


• redness and swelling of the skin


• seeing, hearing, or feeling things that are not there


• sensation of burning on the skin


• severe mood or mental changes


• skin rash, itching, or redness


• trembling


• unusual behavior

Incidence not known

• Black, tarry stools


• bleeding gums


• blurred vision


• breathing difficulty


• burning, numbness, tingling, or painful sensations


• convulsions (seizures)


• cough


• dark-colored urine


• difficulty with chewing, talking, or swallowing


• double vision


• drooping eyelids


• fast or irregular heartbeat


• general body swelling


• hives


• hoarseness


• joint or muscle pain


• muscle cramps, spasms, pain, or stiffness


• peeling or loosening of the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• severe dizziness


• severe tiredness


• shortness of breath


• sore throat


• swollen glands


• tightness in the chest


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• voice changes


• weakness in the arms, hands, legs, or feet


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abdominal or stomach pain or discomfort


• change in taste


• constipation


• diarrhea


• dizziness


• drowsiness


• headache


• lightheadedness


• nausea


• nervousness


• trouble with sleeping


• vaginal itching and discharge


• vomiting

Incidence not known

• Feeling faint


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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More levofloxacin resources

• Levofloxacin Use in Pregnancy & Breastfeeding
• Drug Images
• Levofloxacin Drug Interactions
• Levofloxacin Support Group
• 157 Reviews for Levofloxacin - Add your own review/rating

• Levofloxacin Prescribing Information (FDA)


• Levofloxacin Professional Patient Advice (Wolters Kluwer)


• Levofloxacin Monograph (AHFS DI)


• Levofloxacin MedFacts Consumer Leaflet (Wolters Kluwer)


• Levaquin Prescribing Information (FDA)


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Clindamycin Suspension

Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Cleocin Pediatric

Infrequently, there are severe, rarely fatal, intestinal problems that can occur after use of Clindamycin Suspension. Consult your doctor right away if you develop persistent diarrhea, stomach pain, or blood or mucus in your stool. These symptoms may occur weeks after stopping use of Clindamycin Suspension. Do not use antidiarrhea products or narcotic pain medicines if you have these symptoms. These products may make the symptoms worse. Your doctor will monitor you closely while you are using Clindamycin Suspension.

Clindamycin Suspension is used for:

Treating serious infections caused by certain bacteria.

Clindamycin Suspension is a lincomycin antibiotic. Clindamycin Suspension kills sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.

Do NOT use Clindamycin Suspension if:

• you are allergic to any ingredient in Clindamycin Suspension or to lincomycin


• you have certain intestinal problems (eg, antibiotic-associated colitis, Crohn disease, ulcerative colitis) or meningitis


• you are taking erythromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Clindamycin Suspension:

Some medical conditions may interact with Clindamycin Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea, or a history of liver problems or stomach or bowel problems (eg, colitis)


• if you have been very ill

Some MEDICINES MAY INTERACT with Clindamycin Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because the risk of their side effects may be increased by Clindamycin Suspension


• Erythromycin because it may decrease Clindamycin Suspension's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clindamycin Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Clindamycin Suspension:

Use Clindamycin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Clindamycin Suspension by mouth with or without food.


• Shake well before each use.


• Take Clindamycin Suspension with a full glass of water (8 oz/240 mL).


• Clindamycin Suspension works best if it is taken at the same time each day.


• To clear up your infection completely, take Clindamycin Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Clindamycin Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Clindamycin Suspension.

Important safety information:

• Clindamycin Suspension only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Clindamycin Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Clindamycin Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Tell your doctor or dentist that you take Clindamycin Suspension before you receive any medical or dental care, emergency care, or surgery.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Clindamycin Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Clindamycin Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially diarrhea.


• Use Clindamycin Suspension with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clindamycin Suspension while you are pregnant. Clindamycin Suspension is found in breast milk. If you are or will be breast-feeding while you use Clindamycin Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Clindamycin Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild diarrhea; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; decreased urination; joint pain or swelling; red, swollen, blistered, or peeling skin; severe or persistent diarrhea; severe stomach cramps or pain; unusual vaginal discharge, itching, or odor; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Clindamycin Suspension:

Store Clindamycin Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not refrigerate. Do not store in the bathroom. Throw away any unused medicine after 2 weeks. Keep Clindamycin Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Clindamycin Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Clindamycin Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Clindamycin Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Cemill 1000

Generic Name: ascorbic acid (vitamin C) (as KORE bik AS id)

Brand Names: Acerola, Ascorbic Acid Quick Melts, C-Time, C/Rose Hips, Cecon, Cemill 1000, Cemill 500, Ester-C, N Ice with Vitamin C, Sunkist Vitamin C, Vicks Vitamin C Drops, Vitamin C, Vitamin C TR, Vitamin C with Rose Hips

What is ascorbic acid?

Ascorbic acid (vitamin C) occurs naturally in foods such as citrus fruit, tomatoes, potatoes, and leafy vegetables. Ascorbic acid is important for bones and connective tissues, muscles, and blood vessels. Vitamin C also helps the body absorb iron, which is needed for red blood cell production.

Ascorbic acid is used to treat and prevent vitamin C deficiency.

Ascorbic acid may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ascorbic acid?

You should not use this medication if you have ever had an allergic reaction to ascorbic acid.

Ask a doctor or pharmacist about using ascorbic acid if you have kidney disease or a history of kidney stones, liver disease (especially cirrhosis), or an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

It is not known whether ascorbic acid is harmful to an unborn baby or a nursing baby. Some vitamins and minerals are needed during pregnancy or for breast milk production, but some may be harmful if taken in large doses. Do not take ascorbic acid without telling your doctor if you are pregnant or breast-feeding.

Ascorbic acid can be harmful to the kidneys, and this effect is increased when ascorbic acid is used together with other medicines that can harm the kidneys. Before taking ascorbic acid, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, or any injected antibiotics. You may need dose adjustments or special tests when taking any of these medications together with ascorbic acid.

Before taking ascorbic acid, tell your doctor about all other medications you take.

Stop using ascorbic acid and call your doctor at once if you have severe pain in your lower back or side, blood in your urine, pain when you urinate, severe or ongoing diarrhea, or feel like you might pass out.

What should I discuss with my healthcare provider before taking ascorbic acid?

You should not use this medication if you have ever had an allergic reaction to ascorbic acid.

Ask a doctor or pharmacist about using ascorbic acid if you have:

• kidney disease or a history of kidney stones;


• liver disease (especially cirrhosis); or


• 
  

  an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

  
  

It is not known whether ascorbic acid is harmful to an unborn baby. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Do not take ascorbic acid without telling your doctor if you are pregnant. Ascorbic acid can pass into breast milk, but it is not known whether it would be harmful to a nursing baby. Some vitamins and minerals are needed for breast milk production, but some may harm a nursing baby. Do not take ascorbic acid without telling your doctor if you are breast-feeding a baby.

How should I take ascorbic acid?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

The recommended dietary allowance of ascorbic acid increases with age, and whether you are pregnant or breast-feeding. Follow your doctor's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Take the ascorbic acid regular tablet or capsule with a full glass (8 ounces) of water.

The ascorbic acid chewable tablet must be chewed before swallowing. Ascorbic acid gum may be chewed over a long period and then spit out and thrown away.

Remove the disintegrating tablet from the package using dry hands, and place the tablet in your mouth. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Dissolve the powder form of ascorbic acid in a small amount of water or other liquid. Follow the directions on the package label about what types of liquid you may use. Stir the mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Store ascorbic acid at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of ascorbic acid is not likely to cause life-threatening symptoms.

What should I avoid while taking ascorbic acid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Smoking can make ascorbic acid less effective.

Ascorbic acid side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using ascorbic acid and call your doctor at once if you have a serious side effect such as:

• 
  

  severe pain in your lower back or side;

  
  


• 
  

  blood in your urine;

  
  


• 
  

  pain when you urinate;

  
  


• 
  

  severe or ongoing diarrhea; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  heartburn, stomach cramps;

  
  


• 
  

  nausea, vomiting, diarrhea;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  flushing (warmth, redness, or tingling under your skin);

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ascorbic acid?

Ascorbic acid can be harmful to the kidneys, and this effect is increased when ascorbic acid is used together with other medicines that can harm the kidneys. Before taking ascorbic acid, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, or any injected antibiotics.

You may need dose adjustments or special tests when taking any of these medications together with ascorbic acid.

The following drugs can interact with ascorbic acid. Tell your doctor if you are using any of these:

• 
  

  aspirin or acetaminophen (Tylenol);

  
  


• 
  

  fluphenazine (Permitil);

  
  


• 
  

  indinavir (Crixivan);

  
  


• 
  

  levodopa (Atamet, Larodopa, Parcopa, Sinemet);

  
  


• 
  

  nicotine patches (Nicoderm, Habitrol, Commit);

  
  


• 
  

  antacids that contain aluminum (such as Amphojel, Maalox, Mylanta, Rulox, and others);

  
  


• 
  

  an antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  
  


• 
  

  birth control pills or hormone replacement therapy, including Premarin, Estratest, Vivelle, Climara, Estring, Estrace, and others; or

  
  


• 
  

  a blood thinner such as warfarin (Coumadin).

  
  

This list is not complete and there may be other drugs that can interact with ascorbic acid. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cemill 1000 resources

• Cemill 1000 Side Effects (in more detail)
• Cemill 1000 Use in Pregnancy & Breastfeeding
• Cemill 1000 Drug Interactions
• Cemill 1000 Support Group
• 0 Reviews for Cemill000 - Add your own review/rating

• Cemill 1000 Advanced Consumer (Micromedex) - Includes Dosage Information


• Ascorbic Acid Monograph (AHFS DI)


• Ascorbic Acid MedFacts Consumer Leaflet (Wolters Kluwer)


• Acerola Natural MedFacts for Consumers (Wolters Kluwer)


• Acerola Natural MedFacts for Professionals (Wolters Kluwer)


• Cecon Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cenolate Injection MedFacts Consumer Leaflet (Wolters Kluwer)


• Cevi-Bid Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cemill 1000 with other medications

• Dietary Supplementation
• Scurvy
• Urinary Acidification

Where can I get more information?

• Your doctor, pharmacist, or health care provider may have more information about ascorbic acid.

See also: Cemill000 side effects (in more detail)

Kefadim Vials

1. Name Of The Medicinal Product

'Kefadim'.

2. Qualitative And Quantitative Composition

			Vial Size
		500mg	1g	2g
Active constituent
	Ceftazidime pentahydrate	580mg	1.16g	2.33g
	equivalent to ceftazidime	500mg	1.0g	2.0g
Other constituents
	Sodium carbonate	59mg	118mg	236mg

3. Pharmaceutical Form

Powder for solution for injection

4. Clinical Particulars

4.1 Therapeutic Indications

Kefadim is indicated in the treatment of the following infections when due to susceptible micro- organisms:

Lower respiratory tract infections

Skin and soft tissue infections

Bone and joint infections

Urinary tract infections

Gynaecological infections

Intra-abdominal infections, including peritonitis

Septicaemia

Central nervous system infections, including meningitis. In meningitis, it is recommended that the results of a sensitivity test are known before treatment with ceftazidime as a single agent.

Kefadim may be used alone in cases of confirmed or suspected sepsis. It may also be used concomitantly with other antibiotics, such as aminoglycosides, in severe and life-threatening infections and in the immunocompromised patient.

4.2 Posology And Method Of Administration

Ceftazidime may be given intravenously or by deep intramuscular injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus, or lateral part of the thigh).

The guidelines for dosage of Kefadim are listed in Table 1.

Table 1: Recommended Dosage Schedule for Kefadim

	DOSE	FREQUENCY
Adults
Usual recommended dose	1g IV or im	q 8 or 12 h
Uncomplicated urinary tract infections	250mg IV or im	q 12 h
Bone and joint infections	2g IV	q 12 h
Complicated urinary tract infections	500mg IV or im	q 8 or 12 h
Uncomplicated pneumonia; mild skin and skin-structure infections	500mg-1g IV or im	q 8 h
Serious gynaecological and intra-abdominal infections	2g IV	q 8 h
Meningitis	2g IV	q 8 h
Very severe life-threatening infections, especially in immunocompromised patients	2g IV	q 8 h
Pseudomonal lung infections in patients with cystic fibrosis with normal renal function*	30-50mg/kg IV to a maximum of 6g/day	q 8 h
Neonates and children up to 2 months	12.5-30mg/kg IV	q 12 h
Infants and children (2 months to 12 years of age)	17-50mg/kg IV to a maximum of 6g/day**	q 8 h

*Although clinical improvement has been shown, complete eradication of infecting organisms cannot be expected in patients with chronic respiratory disease and cystic fibrosis.

**The higher dose should be reserved for immunocompromised children or children with cystic fibrosis or meningitis.

Adults and the elderly: The usual dosage range for ceftazidime is 500mg to 2g every eight to twelve hours. The dosage and route of administration should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.

In view of the reduced clearance of ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 2g, especially in those over 80 years of age (Table 2).

Infants and children over 2 months of age: The dosage range is 50-150mg/kg/day IV, in three divided doses, with a maximum of 6g/day. The higher dose should be reserved for immunocompromised children, or children with cystic fibrosis or meningitis.

Neonates and children up to 2 months of age: The dosage range is 25 to 60mg/kg/day, given as two divided doses. In the neonate, the serum half-life of ceftazidime can be three to four times that in adults.

Dosage in impaired renal function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (GFR <50ml/min), it is recommended that the dose of ceftazidime should be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1g may be given. An estimate of GFR should be made to determine the appropriate maintenance dose. The recommended dosage is shown in Table 2.

Table 2: Recommended Maintenance Dosage of Kefadim in Patients with Renal Insufficiency

CREATININE CLEARANCE (ML/MIN)	RECOMMENDED DOSE OF KEFADIM	FREQUENCY
50-31	1g	q 12 h
30-16	1g	q 24 h
15-6	500mg	q 24 h
<5	500mg	q 48 h

When only serum creatinine is available, the following formula (Cockcroft's equation) may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

Males:

Females:

0.85 x above value

In patients with severe infections who would normally receive 6g of Kefadim daily, were it not for renal insufficiency, the dose in Table 2 may be increased by 50% or the dosing frequency increased appropriately. Continued dosage should be determined by further monitoring of creatinine clearance, severity of the infection, and susceptibility of the causative organism. In such patients, it is recommended that ceftazidime serum levels should be monitored and trough levels should not exceed 40mg/litre.

In children, as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency reduced in cases of renal insufficiency.

The serum half-life of ceftazidime during haemodialysis ranges from 3 to 5 hours.

In patients undergoing haemodialysis, a loading dose of 1g of Kefadim is recommended, followed by 1g after each haemodialysis period. Kefadim can also be used in patients undergoing intraperitoneal and continuous ambulatory peritoneal dialysis (CAPD). In such patients, a loading dose of 1g of Kefadim may be given, followed by 500mg every 24 hours. In addition to intravenous use, Kefadim can be incorporated in the dialysis fluid at a concentration of 250mg for 2 litres of dialysis fluid.

NOTE: Kefadim should generally be continued for 2 days after the signs and symptoms of infection have disappeared, however, in complicated infections, longer therapy may be required.

Intramuscular administration: Kefadim should be reconstituted with Water for Injections PhEur or 0.5% or 1% Lignocaine Hydrochloride Injection BP. Refer to Table 3

Table 3:Preparation of Solutions of Kefadim

	AMOUNT OF DILUENT TO BE ADDED (ML)	APPROXIMATE AVAILABLE VOLUME (ML)	APPROXIMATE CEFTAZIDIME CONCENTRATION (MG/ML)
Intramuscular
500mg	1.5	1.925	260
1g	3.0	3.85	260
Intravenous
500mg	5	5.425	92
1g	10	10.85	92
2g	10	11.7	170
Infusion (100ml)
2g	100*	101.7	20

*Note: Addition should be in 2 stages (see 'Instructions for reconstitution' below).

Intravenous administration: For direct intermittent intravenous administration, reconstitute Kefadim with Water for Injections PhEur (see Table 3). Slowly inject the solution directly into the vein over a period of 3 to 5 minutes or give through the tubing of a giving set. Ceftazidime is compatible with the most commonly used intravenous fluids (see section 6.6).

For intravenous infusion, reconstitute the 2g infusion (100ml) vial with 100ml Water for Injections PhEur or one of the compatible intravenous fluids. Alternatively, reconstitute the 500mg, 1g or 2g vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible intravenous fluids.

Intermittent intravenous infusion with a Y-type giving set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution.

When Kefadim is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use, please follow the recommended techniques of reconstitution described below.

Instructions for reconstitution:

For 500mg im/IV, 1g im/IV and 2g IV vials

1. Inject the diluent and shake well to dissolve. The vials may contain a vacuum to assist injection of the diluent.

2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes.

3. Invert the vial and completely depress the syringe plunger prior to insertion.

4. Insert the needle through the vial stopper. Be sure the needle remains within the solution and withdraw contents of the vial in the usual manner. Pressure in the vial may aid withdrawal.

5. The withdrawn solution may contain carbon dioxide bubbles, which should be expelled from the syringe before injection.

For 2g infusion vials

1. Inject 10ml of the diluent and shake to dissolve. The vials may contain a vacuum to assist injection of the diluent.

2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes.

3. Insert a vent needle to release pressure before adding additional diluent to the vial. Add diluent and then remove the vent needle.

4. Additional pressure that may develop in the vial, especially after storage, should be relieved prior to administration to the patient.

NOTE: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial closure before the product has dissolved.

4.3 Contraindications

Ceftazidime is contra-indicated in patients with known hypersensitivity to ceftazidime or cephalosporin antibiotics.

4.4 Special Warnings And Precautions For Use

Warnings

Before therapy with ceftazidime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to ceftazidime, cephalosporins, penicillins, or other drugs. Ceftazidime should be given only with special caution to patients with type 1 or immediate hypersensitivity reactions to penicillin. If an allergic reaction to ceftazidime occurs, discontinue the drug. Serious acute hypersensitivity reactions may require epinephrine (adrenaline), hydrocortisone, antihistamine, or other emergency measures.

Pseudomembranous colitis has been reported with the use of ceftazidime, other cephalosporins and virtually all broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop diarrhoea in association with antibiotic use. Such colitis may range in severity from mild to life-threatening. Symptoms can appear during or after treatment.

Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.

Precautions

Kefadim has not been shown to be nephrotoxic, however, because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when ceftazidime is administered to such patients to avoid the clinical consequences, eg, seizures due to elevated levels of antibiotics (see section 4.2). Continued dosage should be determined by degree of renal impairment, severity of infection and susceptibility of causative organisms.

As with other antibiotics, prolonged use of Kefadim may result in the overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Kefadim should be used with caution in individuals with a history of gastro-intestinal disease, particularly colitis.

Ceftazidime does not interfere with enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics or potent diuretics, such as furosemide (frusemide). Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity and ototoxicity were not noted when Kefadim was given alone in clinical trials.

4.6 Pregnancy And Lactation

Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Kefadim. There are, however, no controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Ceftazidime is excreted in human milk in low concentrations and consequently caution should be exercised when ceftazidime is administered to a nursing woman.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

The most common side-effects were local reactions following intravenous injection and allergic and gastro-intestinal reactions.

Local effects: Phlebitis or thrombophlebitis, and inflammation at the site of injection.

Hypersensitivity: Pruritus, urticarial rash, fever and very rarely angioedema and anaphylaxis (bronchospasm and/or hypotension).

Skin and subcutaneous tissue disorders: As with other cephalosporins, there have been rare reports of toxic epidermal necrolysis reported in association with ceftazidime.

Gastro-intestinal: Diarrhoea, nausea, vomiting and abdominal pain, pseudomembranous colitis (see section 4.4 - 'Warnings'). Very rarely, oral thrush.

Central nervous system: Headache, dizziness, paraesthesias and bad taste. There have been reports of neurological sequelae, including tremor, myoclonica, convulsions and encephalopathy, in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.

Reproductive system disorder: Candidiasis and vaginitis.

Laboratory test changes (usually transient): Eosinophilia, positive Coombs' test without haemolysis, thrombocytosis and slight elevations in one or more hepatic enzymes: AST (SGOT), ALT (SGPT), LDH, GGT and alkaline phosphatase. Transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed occasionally. Transient leucopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis have been seen very rarely.

4.9 Overdose

Signs and symptoms: Toxic signs and symptoms following an overdose of ceftazidime may include pain, inflammation and phlebitis at the injection site. Overdosage can lead to neurological sequelae, including encephalopathy, convulsions and coma.

The administration of inappropriately large doses of parenteral cephalosporins may cause dizziness, paraesthesias and headaches. Seizures may occur following overdosage with some cephalosporins, particularly in patients with renal impairment in whom accumulation is likely to occur.

Laboratory abnormalities that may occur after an overdose include elevations in creatinine, BUN, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia, eosinophilia, leucopenia and prolongation of the prothrombin time.

The subcutaneous median lethal dose in rats and mice ranged from 5.8 to 20g/kg and the intravenous median lethal dose in rabbits was >2g/kg.

Treatment: If seizures occur, the drug should be discontinued promptly; anti-convulsant therapy may be administered if clinically indicated. An airway should be established. Cardiac and vital signs monitoring is recommended, along with general symptomatic and supportive measures.

In cases of severe overdosage, especially in a patient with renal failure, combined haemodialysis and haemoperfusion may be considered if response to more conservative therapy fails.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ceftazidime is a semi-synthetic, beta-lactam antibiotic, for parenteral administration.

In vitro tests demonstrate that ceftazidime is bactericidal. It acts against a wide range of Gram-negative organisms, including strains resistant to gentamicin and other aminoglycosides. It is also active against Gram-positive organisms, and is highly stable to most clinically important beta-lactamases, whether plasmid or chromosomally mediated.

Ceftazidime has been shown to have in vitro activity against the following organisms:

Pseudomonas spp. (including Pseudomonas aeruginosa); Klebsiella spp. (including Klebsiella pneumoniae); Proteus mirabilis and Proteus vulgaris; Morganella morganii (formerly Proteus morganii); Providencia spp. (including Providencia rettgeri, formerly Proteus rettgeri); Escherichia coli; Enterobacter spp.; Citrobacter spp.; Serratia spp.; Salmonella spp.; Shigella spp.; Yersinia enterocolitica; Pasteurella multocida; Acinetobacter spp.; Neisseria gonorrhoeae; Neisseria meningitidis; Haemophilus influenzae (including ampicillin-resistant strains); Haemophilus parainfluenzae (including ampicillin-resistant strains); Staphylococcus aureus (methicillin-sensitive strains); Staphylococcus epidermidis (methicillin-sensitive strains); Streptococcus pyogenes; Streptococcus Group B; Streptococcus pneumoniae; Streptococcus spp.; Peptococcus spp.; Peptostreptococcus spp.; Clostridium spp.; (but not C. difficile); Bacteroides spp. (but most strains of B. fragilis are resistant).

Using the ICS agar dilution method (or its equivalent) for susceptibility testing, the criteria for dilution methods are:

MIC <16mg/litre:	Susceptible
MIC>16 but <64mg/litre:	Moderately susceptible (ie, susceptible to high dosage or if infection confined to tissues or fluids [eg, urine] in which high antibiotic levels are attained)
MIC	Resistant

and for the standard disc test using a 30 microgram ceftazidime disc, are (zone diameters):

Zone	Susceptible
Zone 15-17mm:	Moderately susceptible
Zone	Resistant

Ceftazidime is not active in vitro against methicillin-resistant staphylococci; Streptococcus faecalis and many other enterococci; Listeria monocytogenes; Campylobacter spp. or C. difficile.

Ceftazidime and the aminoglycosides have been shown to be synergistic in vitro against some strains of P. aeruginosa and the Enterobacteriaceae. Ceftazidime and carbenicillin have also been shown to be synergistic in vitro against P. aeruginosa

5.2 Pharmacokinetic Properties

After intravenous administration of 500mg or 1g of ceftazidime, over 5 minutes, to normal adults, mean peak serum concentrations were 45mg/litre and 90mg/litre, respectively. Following intravenous infusion of 500mg, 1g and 2g of ceftazidime, over 20 to 30 minutes, to normal adults, mean peak serum concentrations of 42, 69 and 170mg/litre, respectively, were achieved. The average serum concentrations in these adults, over an 8 hour period, are given in Table 4.

Table 4:Ceftazidime Concentrations in Serum

CEFTAZIDIME DOSAGE (IV)	SERUM CONCENTRATIONS (MG/LITRE)
	0.5h	1h	2h	4h	8h
500mg	42	25	12	6	2
1g	60	39	23	11	3
2g	129	75	42	13	5

Following intramuscular administration of 500mg and 1g ceftazidime to normal adults, mean peak serum concentrations at approximately 1 hour were 17mg/litre and 39mg/litre, respectively. Serum concentrations remained above 4mg/litre for 6 and 8 hours after the intramuscular administration of 500mg and 1g doses, respectively.

The half-life of ceftazidime was approximately 1.9 hours after intravenous administration and 2 hours after intramuscular administration.

Less than 10% of ceftazidime was protein bound and the degree of protein binding was independent of concentration.

Following multiple intravenous doses of 1g and 2g every 8 hours for 10 days, there was no evidence of accumulation of ceftazidime in the serum of individuals with normal renal function.

The presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime in individuals who received 2g intravenously every 8 hours for 5 days. Therefore, dosage adjustment is not required for patients with hepatic dysfunction, unless renal function is also impaired.

Approximately 80% to 90% of a dose of ceftazidime is excreted unchanged by the kidneys over a 24 hour period. The elimination of ceftazidime by the kidneys resulted in high urinary concentrations.

Concentrations of ceftazidime in excess of the minimum inhibitory levels of common pathogens can be achieved in tissues such as bone, heart, bile, sputum, aqueous humour, synovial, pleural and peritoneal fluids.

Transplacental transfer of the antibiotic readily occurs.

Ceftazidime penetrates the intact blood-brain barrier poorly and low levels are achieved in the CSF in the absence of inflammation. Therapeutic levels of 4 to 20mg/litre or more are achieved in the CSF when the meninges are inflamed.

5.3 Preclinical Safety Data

Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium carbonate.

6.2 Incompatibilities

Solutions of Kefadim, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction. However, if concurrent therapy with Kefadim and an aminoglycoside is indicated, each of these antibiotics should be administered in different sites.

Precipitation has been reported when vancomycin has been added to ceftazidime in solution. Therefore, it would be prudent to flush giving sets and intravenous lines between administration of these two agents.

Kefadim is less stable in Sodium Bicarbonate Injection than in other intravenous fluids. Sodium Bicarbonate Injection is not recommended as a diluent. Solutions of Kefadim in 5% Dextrose or 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers and volume control devices of common intravenous infusion sets

6.3 Shelf Life

Unreconstituted vials: 2 years.

Reconstituted vials: It is good practice to reconstitute immediately prior to use. If this is not feasible, Kefadim should be stored in a refrigerator and used within 24 hours. After reconstitution, protection from light is not necessary. The pH of freshly reconstituted solutions ranges from 5.0 to 7.5.

6.4 Special Precautions For Storage

Unreconstituted vials: Protect from light. Do not store above 25°C.

6.5 Nature And Contents Of Container

Kefadim is supplied as a sterile dry powder in single-dose flint Type I or III glass vial with a rubber closure and aluminium seal containing 500mg, 1g and 2g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime).

The total sodium content of the mixture is approximately 54mg (2.3mEq) per gram of ceftazidime

6.6 Special Precautions For Disposal And Other Handling

Solutions of Kefadim range from light yellow to amber, depending on the diluent and concentration.

Kefadim is compatible with the more commonly used intravenous infusion fluids. Solutions at concentrations between 1mg/ml and 40mg/ml in the following infusion fluids may be stored for up to 24 hours at room temperature: 0.9% Sodium Chloride Injection BP; M/6 Sodium Lactate Injection BP; Ringer's Injection USP; Lactated Ringer's Injection USP; 5% Dextrose Injection BP; 0.225% Sodium Chloride and 5% Dextrose Injection BP; 0.45% Sodium Chloride and 5% Dextrose Injection BP; 0.9% Sodium Chloride and 5% Dextrose Injection BP; 10% Dextrose Injection BP; and 10% Invert Sugar in Water for Injection.

At a concentration of 4mg/ml, Kefadim has been found compatible for 24 hours at room temperature in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with cefuroxime sodium, 3mg/ml; heparin, 10u/ml or 50u/ml; or potassium chloride, 10mEq/l or 40mEq/l.

Parenteral drug products should be inspected visually and cloudy solutions should be discarded.

Kefadim powder and solutions will darken, depending on storage conditions. However, product potency is not adversely affected if storage conditions and storage periods are observed.

7. Marketing Authorisation Holder

Flynn Pharma Ltd

Alton House

4 Herbert Street

Dublin 2

Ireland

8. Marketing Authorisation Number(S)

Vials 500mg:	PL 13621/0014
Vials 1g:	PL 13621/0015
Vials 2g:	PL 13621/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation:	1st June 2005

10. Date Of Revision Of The Text

1^st June 2005

Analpram Advanced

Generic Name: diosmiplex, hydrocortisone, and pramoxine (dye OS me plex, HYE droe KORT i sone, and pra MOX een)

Brand Names: Analpram Advanced

What is diosmiplex, hydrocortisone, and pramoxine ?

Diosmiplex (Vasculera) is a medical food for people with chronic venous insufficiency, a blood circulation disorder. Diosmiplex affects the function of blood vessels in the body.

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Diosmiplex is a oral tablet you take by mouth. Diosmiplex, hydrocortisone, and pramoxine are combined into a cream to be applied to the rectum. The two forms of medicine are supplied in a kit that also contains cleansing wipes.

The diosmiplex, hydrocortisone, and pramoxine kit is used to treat itching, swelling, or irritation caused by hemorrhoids.

Diosmiplex, hydrocortisone, and pramoxine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about diosmiplex, hydrocortisone, and pramoxine ?

You should not use this medication if you are allergic to diosmiplex, hydrocortisone, or pramoxine.

Before using diosmiplex, hydrocortisone, and pramoxine , tell your doctor if you have liver or kidney disease, diabetes, or a history of cancer.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone. Do not cover the treated rectal areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the area that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication. Do not use diosmiplex, hydrocortisone, and pramoxine to treat any condition that has not been checked by your doctor.

What should I discuss with my healthcare provider before taking diosmiplex, hydrocortisone, and pramoxine ?

You should not use this medication if you are allergic to diosmiplex, hydrocortisone, or pramoxine.

To make sure you can safely use this medication, tell your doctor if you have any of these other conditions:

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  liver disease;

  
  


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  kidney disease; or

  
  


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  if you have ever had cancer.

  
  

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether diosmiplex, hydrocortisone, and pramoxine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

How should I use diosmiplex, hydrocortisone, and pramoxine ?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Before you apply the rectal cream, clean the rectal area with a cleansing wipe provided with the Analpram Advanced kit. Follow the directions on the label.

Use only a small amount of medicine when applying the hydrocortisone and pramoxine cream around the outside of the rectum. You may apply the cream 3 to 4 times daily or as directed by your doctor.

Do not cover the treated rectal area with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the area that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use diosmiplex, hydrocortisone, and pramoxine for any condition that has not been checked by a doctor.

Contact your doctor if your condition does not improve or if it gets worse after using this medication. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone applied to the rectum is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking diosmiplex, hydrocortisone, and pramoxine ?

Avoid getting this medication in your eyes.

Avoid applying other rectal medications on the same treatment area with diosmiplex, hydrocortisone, and pramoxine , unless your doctor has told you to.

Diosmiplex, hydrocortisone, and pramoxine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

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  severe burning, itching or irritation of the treated area; or

  
  


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  rectal bleeding.

  
  

Less serious side effects may include:

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  mild burning, itching, or dryness of the treated area.

  
  


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  headache;

  
  


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  mild skin rash;

  
  


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  leg cramps;

  
  


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  upset stomach; or

  
  


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  swelling in your hands or feet.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect diosmiplex, hydrocortisone, and pramoxine ?

There may be other drugs that can interact with diosmiplex, hydrocortisone, and pramoxine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Where can I get more information?

• Your pharmacist can provide more information about diosmiplex, hydrocortisone, and pramoxine .